neoadjuvant chemoradiation with 5-fu(or capecitabine) and oxaliplatin combined with hyperthermia in rectal cancer

Conditions: Rectal Cancer

Summary: this trial examines the feasibility, effectiveness and safety of a combination of radiotherapy (over a period of five weeks) and chemotherapy (with 5-fu or capecitabine and oxaliplatin) and 10 fractions of deep regional hyperthermia in patients with primary locally advanced or locally recurrent rectal cancer. previous pelvic irradiation in case of a local recurrence is not excluded from the trial. the treatment protocol aims on a preoperatively improved tumor regression allowing less aggressive surgery in primary locally advanced rectal cancer and a higher rate of curative resections in heavily pretreated locally recurrent rectal cancers. primary endpoint of the trial is the feasibility rate of a multimodal regimen consisting of radiochemotherapy and hyperthermia. secondary endpoints are local control, survival rates, and toxicity. it is planned to include a total number of 59 patients over a period of 2.5 years.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologically confirmed, locally advanced or recurrent (any recurrence of tumor within the lesser pelvis; resectable or non-resectable) adenocarcinoma of the rectum (uicc stage iib-iv); distant oligo-metastases may be present. * ecog-performance status \< 2 * sufficient bone marrow function: * wbc \> 3,5 x 10\^9/l * neutrophil granulocytes \> 1,5 x 10\^9/l * platelets \> 100 x 10\^9/l * hemoglobin \> 10 g/dl * sufficient liver function: bilirubin \< 2,0 mg%, sgot, sgpt, alkaline phosphatase, ggt less than 3 times upper limit of normal * serum creatinine \ 50 ml/min * signed study-specific consent form prior to therapy * fertile patients must use effective contraception during and for 6 months after study treatment * considered fit for oxaliplatin and 5-fu-containing combination chemotherapy exclusion criteria: * pelvic radiotherapy during the last 12 months * pregnant or lactating/nursing women * drug addiction * on-treatment participation on other trials * active intractable or uncontrollable infection * prior or concurrent malignancy (≤ 5 years prior to enrolment in study) except rectal cancer or non-melanoma skin cancer or cervical carcinoma figo stage 0-1 if the patient is continuously disease-free * chronic diarrhea (\> nci ctc-grad 1) * chronic inflammatory disease of the intestine * collagen vascular disease * the presence of congenital diseases with increased radiation sensitivity, for example teleangiectatic ataxia, or similar * pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy * myocardial infarction within the past 12 months * congestive heart failure * complete bundle branch block * new york heart association (nyha) class iii or iv heart disease * known allergic reactions on study medication * cardiac pacemaker * disease that would preclude chemoradiation or deep regional hyperthermia * any metal implants (with exception of non-clustered marker clips) * psychological, familial, sociological, or geographical condition that would preclude study compliance * patients deemed technically unsatisfactory for deep regional hyperthermia * cardiac symptoms (\> nci ctcae grade 1) due to pretreatment with fluoropyrimidines * neurological symptoms (\> nci ctcae grade 1) due to pretreatment with oxaliplatin * rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * oral anticoagulation

Keywords: rectal cancer recurrent rectal cancer hyperthermia radiation chemoradiation 5-fu capecitabine oxaliplatin